dc.contributor.advisor	Horváth, László
dc.contributor.author	Girgis, Michael Magdy Fahmy
dc.contributor.authorvariant	Girgis, Michael Magdy Fahmy
dc.contributor.department	Gyógyszertudományok doktori iskola	hu
dc.contributor.submitterdep	Gyógyszerésztudományi Kar
dc.date.accessioned	2024-11-27T06:25:45Z
dc.date.available	2024-11-27T06:25:45Z
dc.date.defended	2024-12-12
dc.date.issued	2024	hu
dc.description.abstract	Epilepsy is a disease needing life-long treatment affecting millions of people. We have focused on two important aspects of treatment in order to achieve better tailored therapy. Firstly, we conducted a pharmacovigilance study of ASMs covering a ten-year-period using EV database with focus on their seriousness and outcomes of reported sADRs. A total of 276,694 reports were retrieved, including1,051,142 individual sADRs reported as PTs. ROR, 95% CI, p value and chi-square statistics were calculated. The most frequent SOCs were the following: nervous system disorders (19.26%), general disorders and administration site conditions (14.39%), psychiatric disorders (11.29%) and injury, poisoning and procedural complications (9.79%). Old ASMs had a significant positive association with ‘caused/prolonged hospitalisation’, ‘congenital anomaly’, ‘disabling’, ‘life threatening’ and ‘results in death’, while new ASMS with ‘other medically important condition’. SUDEP was reported in 0.04% of PTs. Concluding, Old ASMs were generally more commonly associated with undesired outcomes and seriousness. Considering their expected seriousness and outcomes, the safety profile of the different ASMs, can play a major role in the selection of ASMs. Summarizing our PV studies, most of the PTs felt in the serious condition. Undesired outcomes and seriousness among reported ICSR were more common by old ASMs. Only with the precise knowledge of the safety profile of prescribed ASMs can fulfil patients’ preference and lead to adequate adherence increasing the probability of better seizure control. Secondly, CAM use was examined with a self-developed questionnaire focusing on the outcomes of treatment among PWE. Filled questionnaires were used in compiling database that was eventually analysed. Number of PWE was 127. Mean age was 45.1±16.1 years. From PWE group, ten patients (7.9%) used CAM because they believed in CAM. Comparing to patients with diabetes mellitus, the prevalence was 12%. Two of them reported ADR. The CAM users among PWE were younger, while patients with DM were elderly who tended to use CAM. The major findings were that health-conscious patients tended to use more CAM which highlights the necessity to discuss CAM use openly. The most commonly reported CAMs were CYPs enzymes modulating that can lead to many interactions and lead to ADR. Accordingly, role of treating team including clinical pharmacists and patient’s education may be essential. Both studies may show, how a clinical pharmacist could contribute to the treatment of PWE.
dc.format.extent	101
dc.identifier.uri	https://hdl.handle.net/2437/382578
dc.language.iso	en
dc.subject	Epilepsy, Seizure, treatment, Antiseizure medications (ASMs), Adverse events, Adverse drug reactions, Pharmacovigilance, EudraVigilance (EV), System Organ Classifications (SOCs), Outcomes, Seriousness, Sudden Unexpected Death in Epilepsy (SUDEP), Complementary and altern2024ative medicines, epilepsy, diabetes mellitus, seriousness, outcome, adherence
dc.subject.discipline	Gyógyszertudományok	hu
dc.subject.sciencefield	Orvostudományok	hu
dc.title	Pharmacovigilance study of anti-seizure medications among people living with epilepsy and the potential impact of complementary and alternative medicine regarding outcome
dc.title.translated	Pharmacovigilance study of anti-seizure medications among people living with epilepsy and the potential impact of complementary and alternative medicine regarding outcome
dc.type	PhD, doktori értekezés	hu

Pharmacovigilance study of anti-seizure medications among people living with epilepsy and the potential impact of complementary and alternative medicine regarding outcome

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